Revised: 30 October 2020

Medicines

Label Statements Database

Edition 2.01 (April 2021)

This database lists the warning and advisory statements that are required on medicine and related product labels under regulations 13(1)(i) and 14(1)(f) of the Medicines Regulations 1984. Words of a similar meaning to the statements in the database may be used and individual statements may be combined provided the intent is not changed.

The full set of labelling requirements for medicines is specified in the Medicines Regulations 1984 and described in the Medsafe guidance document 'Guideline on the Regulation of Therapeutic Products in New Zealand, Part 5: Labelling of Medicines and Related Products'.

Download the Guideline on the Regulation of Therapeutic Products in New Zealand, Part 5: Labelling of Medicines and Related Products (Word 1.9 MB,19 pages).

Each label statement for a medicine or related product has a "required by" date. This is the date on which inclusion of the statement on labels becomes mandatory. Those label statements that were required prior to August 2011 have been given a "required by" date of 1 August 2011.

The "required by" date for future statements will generally be one year from the date on which the statement was added to the database, to allow distributors to amend product labels.

Required label statements will only be added to the database following consultation with affected parties. In cases where a required label statement is added as the result of a recommendation from the Medicines Classification Committee, consultation will occur through the normal Medicines Classification Committee process.

Explanatory Notes

Unless specifically indicated, the statements do not apply to prescription medicines.

Unless indicated otherwise, the label statements are required for all products containing any proportion of the named ingredient or any form of that ingredient.

In this database "For oral use" means the product is intended to be swallowed.

* Substances marked with an asterisk (*) also require statements of their own in addition to those applicable to their group or class.

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